Analyte sensor transmitter unit configuration for a data monitoring and management system

ABSTRACT

Method and system for providing analyte sensor alignment and retention mechanism for improved connectivity with a transmitter unit for electrical connection, and further including transmitter unit contact pins with metal components to improve electrical conductivity with the analyte sensor in an analyte monitoring and management system is provided.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/210,965, filed Dec. 5, 2018, which is a continuation of U.S.patent application Ser. No. 15/132,119, filed Apr. 18, 2016, now U.S.Pat. No. 10,159,433, which is a continuation of U.S. patent applicationSer. No. 13/252,118, filed Oct. 3, 2011, now U.S. Pat. No. 9,364,149,which is a continuation of U.S. patent application Ser. No. 11/365,334,filed Feb. 28, 2006, now U.S. Pat. No. 8,029,441, all of which areincorporated herein by reference in their entireties for all purposes.

BACKGROUND

Analyte monitoring systems including continuous glucose monitoringsystems generally include an analyte sensor such as a subcutaneousanalyte sensor, at least a portion of which is configured for fluidcontact with biological fluid, for detecting analyte levels such as forexample glucose or lactate levels, a transmitter (such as for example aRadio Frequency (RF) transmitter) in communication with the sensor andconfigured to receive the sensor signals and to transmit them to acorresponding receiver unit by for example, using an RF datatransmission protocol. The receiver may be operatively coupled to aglucose monitor that performs glucose related calculations and dataanalysis.

The transmitter may be mounted or adhered to the skin of a patient andalso in signal communication with the sensor. Generally, the sensor isconfigured to detect the analyte of the patient over a predeterminedperiod of time, and the transmitter is configured to transmit thedetected analyte information over the predetermined period of time forfurther analysis. To initially deploy the sensor so that the sensorcontacts and electrodes are in fluid contact with the patient's analytefluids, a separate deployment mechanism such as a sensor inserter orintroducer is used. Moreover, a separate base component or mounting unitis provided on the skin of the patient so that the transmitter unit maybe mounted thereon, and also, to establish signal communication betweenthe transmitter unit and the analyte sensor.

As discussed above, the base component or mounting unit is generallyadhered to the skin of the patient using an adhesive layer that isfixedly provided on the bottom surface of the base component or themounting unit for the transmitter.

To minimize data errors in the continuous or semi-continuous monitoringsystem, it is important to properly insert the sensor through thepatient's skin and securely retain the sensor during the time that thesensor is configured to detect analyte levels. In addition to accuratepositioning of the sensor through the skin of the patient, it isimportant to ensure that the appropriate electrode of the analyte sensorare in continuous and proper electrical connection or communication withthe corresponding contact points or pads on the transmitter unit.

Additionally, for the period of continuous or semi-continuous monitoringwhich can include, for example, 3 days, 5 days or 7 days, it isimportant to have the transmitter unit securely mounted to the patient,and more importantly, in proper contact with the analyte sensor so as tominimize the potential errors in the monitored data.

In view of the foregoing, it would be desirable to have an approach toprovide methods and system for accurate and simple ways in which tosecurely couple the analyte sensor with the transmitter unit so as tomaintain continuous electrical connection therebetween. Moreover, itwould be desirable to have methods and system for easy deployment ofsensors and subsequent simple removal of the same in a time effectiveand straight forward manner.

SUMMARY

In accordance with the various embodiments of the present invention,there is provided method and system for providing analyte sensoralignment and retention mechanism for improved connectivity with atransmitter unit for electrical connection, and further includingtransmitter unit contact pins with metal components to improveelectrical conductivity with the analyte sensor in an analyte monitoringand management system.

These and other objects, features and advantages of the presentinvention will become more fully apparent from the following detaileddescription of the embodiments, the appended claims and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating a data monitoring and managementsystem in accordance with one embodiment of the present invention;

FIGS. 2A-2D illustrate various views of the analyte sensor alignmentwith a transmitter unit in accordance with one embodiment of the presentinvention;

FIGS. 3A-3D illustrate various views of the analyte sensor alignmentwith a transmitter unit in accordance with another embodiment of thepresent invention;

FIGS. 4A-4E illustrate various views of the analyte sensor latchconfiguration in accordance with one embodiment of the presentinvention;

FIGS. 5A-5C illustrate various views of the analyte sensor latchconfiguration in accordance with another embodiment of the presentinvention;

FIGS. 6A-6D illustrate various views of the analyte sensor latchconfiguration in accordance with yet another embodiment of the presentinvention;

FIGS. 7A-7E illustrate a transmitter unit interconnect configuration inaccordance with one embodiment of the present invention; and

FIGS. 8A-8C illustrate a polymer pin with contact cap of the transmitterunit interconnect shown in FIGS. 7A-7E in one embodiment of the presentinvention.

DETAILED DESCRIPTION

FIG. 1 illustrates a data monitoring and management system such as, forexample, an analyte monitoring and management system 100 in accordancewith one embodiment of the present invention. In such embodiment, theglucose monitoring system 100 includes a sensor 101, a transmitter unit102 coupled to the sensor 101, and a receiver unit 104 which isconfigured to communicate with the transmitter 102 via a communicationlink 103. The receiver unit 104 may be further configured to transmitdata to a data processing terminal 105 for evaluating the data receivedby the receiver unit 104. In addition, as shown in the Figure, amedication delivery unit 106 may be provided and operatively coupled tothe receiver unit 104 and configured to receive one or more of data orcommands directed to the control of the medication delivery unit 106 fordelivering medication to a patient such as insulin.

Only one sensor 101, transmitter unit 102, communication link 103,receiver unit 104, data processing terminal 105, and medication deliveryunit 106 are shown in the embodiment of the analyte monitoring andmanagement system 100 illustrated in FIG. 1. However, it will beappreciated by one of ordinary skill in the art that the glucosemonitoring system 100 may include one or more sensor 101, transmitterunit 102, communication link 103, receiver unit 104, and data processingterminal 105, where each receiver unit 104 is uniquely synchronized witha respective transmitter unit 102 to deliver medication through themedication delivery unit 106 such as an infusion pump. Moreover, withinthe scope of the present invention, the analyte monitoring andmanagement system 100 may be a continuous monitoring and managementsystem, or a semi-continuous or discrete monitoring and managementsystem.

In one embodiment of the present invention, the sensor 101 is physicallypositioned on the body of a user whose glucose level is being monitored.The sensor 101 may be configured to continuously sample the glucoselevel of the user and convert the sampled analyte level into acorresponding data signal for transmission by the transmitter unit 102.In one embodiment, the transmitter unit 102 is mounted on the sensor 101so that both devices are positioned on the user's body. The transmitterunit 102 performs data processing such as filtering and encoding on datasignals, each of which corresponds to a sampled analyte level of theuser, for transmission to the receiver unit 104 via the communicationlink 103.

In one embodiment, the analyte monitoring and management system 100 isconfigured as a one-way RF communication path from the transmitter unit102 to the receiver unit 104. In such embodiment, the transmitter unit102 transmits the sampled data signals received from the sensor 101without acknowledgement from the receiver unit 104 that the transmittedsampled data signals have been received. For example, the transmitterunit 102 may be configured to transmit the encoded sampled data signalsat a fixed rate (e.g., at one minute intervals) after the completion ofthe initial power on procedure. Likewise, the receiver unit 104 may beconfigured to detect such transmitted encoded sampled data signals atpredetermined time intervals. Alternatively, the analyte monitoring andmanagement system 100 may be configured with a bi-directional RFcommunication between the transmitter unit 102 and the receiver unit104.

Additionally, in one aspect, the receiver unit 104 may include twosections. The first section is an analog interface section that isconfigured to communicate with the transmitter unit 102 via thecommunication link 103. In one embodiment, the analog interface sectionmay include an RF receiver and an antenna for receiving and amplifyingthe data signals from the transmitter 102, which are thereafter,demodulated with a local oscillator and filtered through a band-passfilter. The second section of the receiver unit 104 is a data processingsection which is configured to process the data signals received fromthe transmitter unit 102 such as by performing data decoding, errordetection and correction, data clock generation, and data bit recovery.

In operation, upon completing the power-on procedure, the receiver unit104 is configured to detect the presence of the transmitter unit 102within its range based on, for example, the strength of the detecteddata signals received from the transmitter unit 102 or a predeterminedtransmitter identification information. Upon successful synchronizationwith the corresponding transmitter unit 102, the receiver unit 104 isconfigured to begin receiving from the transmitter unit 102 data signalscorresponding to the user's detected glucose level. More specifically,the receiver unit 104 in one embodiment is configured to performsynchronized time hopping with the corresponding synchronizedtransmitter unit 102 via the communication link 103 to obtain the user'sdetected analyte level.

Referring again to FIG. 1, the data processing terminal 105 may includea desktop computer terminal, a data communication enabled kiosk, alaptop computer, a handheld computing device such as a personal digitalassistant (PDAs), or a data communication enabled mobile telephone, andthe like, each of which may be configured for data communication withthe receiver via a wired or a wireless connection. Additionally, thedata processing terminal 105 may further be connected to a data network(not shown) for storing, retrieving and updating data corresponding tothe detected glucose level of the user. In addition, the data processingterminal 105 in one embodiment may include physician's terminal and/or abedside terminal in a hospital environment, for example.

Moreover, the medication delivery unit 106 may include an infusiondevice such as an insulin infusion pump, which may be configured toadminister insulin to patients, and which is configured to communicatewith the receiver unit 104 for receiving, among others, the measuredanalyte level. Alternatively, the receiver unit 104 may be configured tointegrate an infusion device therein so that the receiver unit 104 isconfigured to administer insulin therapy to patients, for example, foradministering and modifying basal profiles, as well as for determiningappropriate boluses for administration based on, among others, thedetected glucose levels received from the transmitter unit 102.Referring again to FIG. 1, the medication delivery unit 106 may include,but is not limited to, an external infusion device such as an externalinsulin infusion pump, an implantable pump, a pen-type insulin injectordevice, a patch pump, an inhalable infusion device for nasal insulindelivery, or any other type of suitable delivery system.

Each of the transmitter unit 102, the receiver unit 104, the dataprocessing unit 105, and the medication delivery unit 106 may beconfigured to communicate with each other over a wireless datacommunication link similar to the communication link 103 such as, butnot limited to, RF communication link, Bluetooth® communication link,infrared communication link, or any other type of suitable wirelesscommunication connection between two or more electronic devices. Thedata communication link may also include wired cable connection such as,for example, but not limited to, RS232 connection, USB connection, orserial cable connection.

Moreover, referring to FIG. 1, the analyte sensor 101 may include, butis not limited to, short term subcutaneous analyte sensors ortransdermal analyte sensors, for example, which are configured to detectanalyte levels of a patient over a predetermined time period.

Additional analytes that may be monitored, determined or detected by theanalyte sensor 101 include, for example, acetyl choline, amylase,bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g.,CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growthhormones, hormones, ketones, lactate, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined.

FIGS. 2A-2D illustrate various views of the analyte sensor alignmentwith a transmitter unit in accordance with one embodiment of the presentinvention. Referring to FIG. 2A, a transmitter unit 102 (FIG. 1) housing210 is provided with a protrusion 220 substantially on the same side asthe location of a plurality of transmitter contacts 230A, 230B, 230C,230D, each of which are configured to couple to a respective segment ofan analyte sensor 250 (FIG. 2B).

That is, when the transmitter unit housing 210 is positioned on anadhesive layer 240 for adhesion to a skin surface of a patient, theprotrusion 220 of the transmitter unit housing 210 is configured tocorrespondingly mate with a notch or hole 260 on the surface of theanalyte sensor 250 such that during the process of placing and guidingthe transmitter unit on the adhesive layer 240 (and upon a transmittermounting unit 270 (FIG. 2C)), it is possible to accurately position andalign the transmitter contacts 230A, 230B, 230C, and 230D and toelectrically couple to a respective one of the working electrode, thecounter electrode, the reference electrode, and a guard trace, providedon the analyte sensor 250. Referring to FIGS. 2C and 2D, side crosssectional view of the transmitter contacts before and after alignmentand engagement with the analyte sensor 250, respectively, are shown.

In the manner described above, in one embodiment of the presentinvention, there is provided a protrusion 220 on the transmitter unithousing 210 which is configured to mate with a notch or hole 260 on theanalyte sensor 250 such that substantially accurate positioning andalignment of the analyte sensor 250 with respect to the transmitter unit102 may be provided.

FIGS. 3A-3D illustrate various views of the analyte sensor alignmentwith a transmitter unit in accordance with another embodiment of thepresent invention. Referring to FIGS. 3A-3B, it can be seen that theanalyte sensor 330 is provided with a seal 340 having a plurality ofsubstantially circular lead-in segments 341A, 341B, 341C, 341D, eachprovided substantially respectively on one of the working electrode,counter electrode, reference electrode, and the guard trace of theanalyte sensor 330. Moreover, referring to FIG. 3C, the electricalcontact pins 350A, 350B, 350C, 350D on the transmitter unit housing 310is each configured in substantially tapered manner extending outwardsand away from the transmitter unit housing 310.

In this manner, in one embodiment of the present invention, when afteranalyte sensor 330 has been subcutaneously positioned through the skinof the patient, the transmitter unit housing 310 may be configured tomate with the transmitter mount unit 360 provided on the adhesive layer320 such that the electrical contact pins 350A, 350B, 350C, 350D guidedby the respective lead-in segments 341A, 341B, 341C, 341D on the sensorseal 340 such that the proper alignment of the sensor electrodes andguard trace are provided to the respective electrical contact pins 350A,350B, 350C, 350D to establish electrical contacts with the same.

FIG. 3D illustrates a side cross sectional view of the electricalcontact pins 350A, 350B, 350C, 350D on the transmitter unit 102 coupledto the respective lead-in segments 341A, 341B, 341C, 341D on the sensorseal 340 to establish electrical contact between the transmitter unit102 (FIG. 1) and the analyte sensor 101. In one embodiment, the sensorseal 340 is provided on the analyte sensor 330 during the sensormanufacturing process, and as such, it is possible to achieve a highdegree of accuracy in positioning the seal 340, and further, to obtain asubstantially concentric lead-in segments 341A, 341B, 341C, 341D asshown, for example, in FIG. 3B, such that when the tip portion of theelectrical contact pins 350A, 350B, 350C, 350D on the transmitter unit102 are positioned within the concentric lead-in segments 341A, 341B,341C, 341D, the proper alignment of the sensor contact pads orelectrodes and guard trace with the respective electrical contact pins350A, 350B, 350C, 350D on the transmitter unit 102 can be achieved.

Referring back to FIG. 3B, the seal 340 on the analyte sensor 330 may beprovided during the manufacturing process of the sensor 330 and as such,pre-bonded to the sensor 330. In this manner, accurate alignment of theanalyte sensor 330 with the transmitter unit 102 with a degree oftolerating potential misalignment of the electrical contact pins 350A,350B, 350C, 350D on the transmitter unit 102 may be tolerated given theconcentric shape of the lead-in segments 341A, 341B, 341C, 341D on theseal 340 of the analyte sensor 330.

FIGS. 4A-4E illustrate various views of the analyte sensor latchconfiguration in accordance with one embodiment of the presentinvention. Referring to FIG. 4A, there is shown a sensor 410 having anupper flap portion 412 and a lower flap portion 411. The lower flapportion of the sensor 410 is configured in one embodiment to retain thesensor in proper position within a sharp or introducer 430 (FIG. 4B) ofan insertion mechanism 420 (FIG. 4B) so as to minimize the potentialsensor displacement prior to positioning the sensor in fluid contactwith the patient's analytes using the insertion mechanism 420.

Referring back to FIG. 4A, the upper flap portion 412 of the sensor 410is configured in one embodiment to facilitate the removal of the sensor410 after its intended use (for example, 3 days, 5 days or 7 days), byproviding an area which may be manually manipulated for removal from theinserted position in the patient. In one embodiment, the upper flapportion 412 and the lower flap portion 411 are extended in oppositedirections relative to the body of the analyte sensor 410. Thisconfiguration further provides secure sensor positioning during thesensor insertion process such that the sensor movement when coupled tothe introducer 430 is minimized. FIG. 4C illustrates the transmittermount 440 in cooperation with the insertion mechanism 420 having thesensor 410 loaded in the introducer 430 before the sensor is placed inthe patient. FIGS. 4D and 4E illustrate the insertion mechanism 420coupled with the transmitter mount 440 after the insertion mechanism hasdeployed the introducer 430 so as to place at least a portion of thesensor 410 in fluid contact with the patient's analytes.

FIGS. 5A-5C illustrate various views of the analyte sensor latchconfiguration in accordance with another embodiment of the presentinvention. Referring to FIGS. 5A-5C, transmitter mount 520 is providedwith a plurality of hooks (or barbs) 521A, 521B, each of which areconfigured to mate with a corresponding one of a plurality of opensegments 511A, 511B on the sensor 510. During deployment of the sensor510 for example, using an insertion mechanism 550 having an introducer540 coupled to the sensor 510, the sensor 510 is positioned relative tothe transmitter mount 520 such that the open segments 511A, 511B of thesensor 510 are coupled or latched with the respective hook/latch 521A,521B on the transmitter mount 520, to securely retain the sensor 510 inposition relative to the transmitter unit 102 being mounted on thetransmitter mount 520 to couple to the sensor 510.

In one embodiment, the plurality of hooks/barbs 521A, 521B on thetransmitter mount 520 are provided as molded plastic protrusions on thetransmitter mount 520. Upon engaging with the respective open segments511A, 511B on the sensor 510, it can be seen that the sensor 510 isretained substantially in a fixed position relative to the transmittermount 520 (which is in turn, fixedly positioned on the patient's skin bythe adhesive layer 530), so that proper alignment and coupling with therespective electrical contact pins on the transmitter unit 102 may beachieved.

FIGS. 6A-6D illustrate various views of the analyte sensor latchconfiguration in accordance with yet another embodiment of the presentinvention. Referring to FIG. 6A illustrating a component view of thelatch configuration, there is provided a transmitter mount 620, adhesivelayer 610, a retaining segment 630 having a plurality of clip portions631A, 631B, and a mounting segment 640. Referring to FIG. 6B, it can beseen that the retaining segment 630 is positioned on the transmittermount 620 with the mounting segment provided thereon. Moreover, thetransmitter mount is provided on the adhesive layer 610, which is inturn, placed on the patient's skin and adhered thereto for securepositioning.

Referring to FIGS. 6C-6D, in one embodiment, the clip portions 631A,631B of the retaining segment 630 are each spring biased and configuredfor spring loading the sensor 650 in the direction towards theelectrical contact pins of the transmitter unit 102, thus facilitatingthe sensor (650)—transmitter (670) connection. Moreover, the clipportions 631A, 631B are further configured to provide a latch/lockingmechanism of the subcutaneously positioned sensor 650 relative to thetransmitter mount 620, such that the sensor 650 is held firmly in place.

In the manner described above, in accordance with the variousembodiments of the present invention, there are provided differentmechanisms for sensor alignment relative to the transmitter electricalcontact pins to effectively couple the sensor contacts (working,reference and counter electrodes and the guard trace), with thecorresponding electrical contact pads or connections on the transmitterunit 102. Moreover, as further described above, in accordance with thevarious embodiments of the present invention, there are providedmechanism for sensor retention and secure positioning relative to thetransmitter mount which is placed on the patient's skin such that thetransmitter unit 102 may be easily and accurately guided to establishproper connection with the sensor 101.

FIGS. 7A-7E illustrate a transmitter unit interconnect configuration inaccordance with one embodiment of the present invention. Morespecifically, FIGS. 7A-7E show various different perspectives and viewsof the transmitter unit housing 710 that includes a plurality ofelectrical contact pins 711A, 711B, 711C, 711D, each configured toestablish electrical connection to a respective portion of the analytesensor 720. As discussed below, each of the electrical contact pins711A, 711B, 711C, 711D in one embodiment includes a polymer pin with acontact cap that provides improved electrical conductivity between thetransmitter unit 102 and the sensor 101.

FIGS. 8A-8C illustrate a polymer pin with contact cap of the transmitterunit interconnect shown in FIGS. 7A-7E in one embodiment of the presentinvention. As shown in FIGS. 8A-8C, contact pin 800 includes an outerbody portion 810 and an inner contact portion 820 with an end segment821. In one embodiment, the inner contact portion 820 is configured tosubstantially entirely be positioned within the outer body portion 810(as shown in FIG. 8A), except for the end segment 821 of the innercontact portion 820 extending out of one end of the outer body portion810.

In one embodiment, the outer body portion 810 may be injection moldedusing a silicone based, carbon loaded (impregnated, for example) softpolymer material. Furthermore, the end segment 821 and the inner contactportion 820 comprise a metal such as for example, Beryllium copper(BeCu), Nickel Silver, Phosphor Bronze Brass, Rhodium or gold plated toprovide improved electrical conductivity. More specifically, the innercontact portion 820 placed within the outer body portion 810 maycomprise a light gauge wire (such as 30 g), and may be insert moldedinto the outer body portion 810.

In this manner, the contact pin 800 in one embodiment includes a carbonloaded, silicone based, injection molded soft polymer pin with a metalcap or end segment 821 which is shaped and positioned to coversubstantially a large portion of the contact area where the sensorcontact is to occur. Moreover, the metal inner contact portion 820extending the length of the outer body portion 810 of the contact pin800 further improves electrical conductivity. Moreover, a metal endsegment 821 provides additional resistance to wear over a prolonged usebased on repeated contact with other surfaces (for example, sensorsurfaces).

Accordingly, in one aspect of the present invention, the transmitterunit 102 may be provided with a plurality of contact pins 800 that havea large metal sensor contact surface to increase the electricalconductivity with the sensor. In addition, the metal contact surface mayprovide improved resistance to abrasion, wear and damage to the endsegment 821 of the contact pin 800. In addition, the contact pin 800configuration described above also provides flexibility, desiredcompliance and self-sealing capability, and further, may be press fitinto the transmitter housing. Further, the contact pins 800 mayadditionally be chemically resistant, substantially water proof, andthus improve the transmitter unit 102 interconnect assembly life.

Accordingly, an apparatus for providing alignment in one embodiment ofthe present invention includes a sensor having a hole thereon, and atransmitter housing including a protrusion at a first end, theprotrusion configured to substantially engage with the hole of thesensor such that the transmitter is in electrical contact with thesensor.

An apparatus for providing alignment in accordance with anotherembodiment of the present invention includes a sensor including aplurality of conductive pads, and a transmitter housing including aplurality of electrical contacts, each of the electrical contactsconfigured to substantially align with a respective one of the pluralityof the conductive pads.

The apparatus may further include a seal segment adhered to the sensor,where the seal segment includes a plurality of radial seal holesdisposed on the seal segment, and further, where each of the radialholes may be configured to receive a respective one of the plurality ofelectrical contacts.

In another aspect, each of the electrical contacts may be substantiallytapered.

Moreover, the transmitter electrical contacts may be configured toself-align with a respective one of the conductive pads of the sensorwhen the transmitter is coupled to the sensor.

An apparatus for providing a sensor connection in a data monitoringsystem in accordance with yet another embodiment of the presentinvention includes a sensor having a plurality of conductive pads, and atransmitter housing, the housing including a plurality of electricalcontacts, each of the contacts configured to substantially contact therespective one of the sensor conductive pads, where each of theplurality of electrical contacts include conductive polymer.

The electrical contacts in one embodiment may be silicon doped withcarbon.

Moreover, the electrical contacts may be substantially conical shaped.

In another aspect, each of the electrical contacts may include a metalcomponent disposed therein, wherein at least a first end of each of theelectrical contacts is configured to substantially contact therespective one of the sensor conductive pads.

The metal component may include one of gold or beryllium copper.

An apparatus for providing a sensor connection in a data monitoringsystem in still another embodiment of the present invention includes asensor having a plurality of conductive pads, a transmitter mount havinga spring biased mechanism, and a transmitter housing, the housingincluding a plurality of electrical contacts, where each of theplurality of electrical contacts of the transmitter is configured tosubstantially contact the respective one of the sensor conductive padsby the spring biased mechanism of the transmitter housing.

In yet another aspect, the spring biased mechanism of the transmittermount may include a tapered cantilever beam disposed on the transmittermount.

An apparatus for positioning a sensor in a data monitoring system in yetstill another embodiment of the present invention may include a sensorhaving a cutout portion, and a transmitter mount having a latchmechanism, the transmitter mount configured to couple to the sensor bythe latch mechanism engaging the cutout portion of the sensor.

An apparatus for positioning a sensor in a data monitoring system in yetstill a further embodiment of the present invention may include asensor, and a transmitter mount, the transmitter including a latchmechanism, the latch mechanism configured to engage with the sensor forsubstantially permanently positioning the sensor relative to thetransmitter.

Further, the latch mechanism may, in one embodiment, include a metalclip.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

1-16. (canceled)
 17. An apparatus comprising: a sensor subassemblycomprising a glucose sensor and a sensor seal, wherein the glucosesensor comprises a first portion configured to be electrically coupledwith a transmitter and a second portion configured to be insertedthrough a skin surface and in fluid contact with a bodily fluid of auser; and a transmitter mount, comprising: a base comprising an aperturethrough which the second portion of the glucose sensor is configured topass before being inserted through the skin surface, and a lockingmechanism configured to engage the sensor subassembly and secure thesensor subassembly in a position for electrical coupling with thetransmitter, wherein movement of the sensor subassembly is impeded whenthe locking mechanism is engaged with the sensor subassembly, whereinthe apparatus is configured to be applied to the skin surface of theuser, and wherein the transmitter mount is configured to couple with thetransmitter after the locking mechanism is engaged with the sensorsubassembly.
 18. The apparatus of claim 17, wherein the lockingmechanism comprises two protrusions configured to secure the sensorsubassembly to the base of the transmitter mount before the transmitteris received in the transmitter mount.
 19. The apparatus of claim 18,wherein the two protrusions of the locking mechanism comprise twolatches each of which is configured to mate with a correspondingopening.
 20. The apparatus of claim 18, wherein the two protrusions ofthe locking mechanism comprise a molded plastic material.
 21. Theassembly of claim 18, wherein the two protrusions of the lockingmechanism comprise two clip portions each of which is disposed on aretaining segment
 22. The apparatus of claim 17, wherein the sensor sealincludes a plurality of radial seal holes disposed on the sensor seal,and wherein each of the radial seal holes is configured to receive oneof a plurality of electrical contacts.
 23. The apparatus of claim 17,wherein the transmitter mount further comprises an opening to detachablycouple with the transmitter.
 24. The apparatus of claim 17, furthercomprising the transmitter.
 25. The apparatus of claim 24, wherein theglucose sensor includes a plurality of conductive contacts and thetransmitter includes a plurality of electrical contacts, and whereineach of the plurality of electrical contacts aligns with a respectiveone of the conductive contacts when the transmitter is coupled with thetransmitter mount.
 26. The apparatus of claim 25, wherein a contactpoint between each of the plurality of electrical contacts and therespective one of the plurality of conductive contacts includes aconductive polymer.
 27. The apparatus of claim 25, wherein each of theplurality of electrical contacts includes a metal component disposedtherein, wherein at least a first end of each of the plurality ofelectrical contacts is configured to substantially contact therespective one of the plurality of conductive contacts of the glucosesensor.
 28. The apparatus of claim 24, wherein the transmitter isconfigured to transmit sensor data to a receiver unit via abi-directional radio frequency (RF) communication path.
 29. Theapparatus of claim 24, wherein the transmitter is configured to transmitsensor data to a receiver unit via a Bluetooth communication link. 30.The apparatus of claim 17, further comprising an adhesive layerconfigured to secure the transmitter mount to the skin surface of theuser.
 31. The apparatus of claim 24, wherein the transmitter isconfigured to transmit predetermined transmitter identificationinformation to a receiver unit.
 32. The apparatus of claim 17, furthercomprising an insertion mechanism configured to position the sensorsubassembly against the base of the transmitter mount by causing themovement of the sensor subassembly until the locking mechanism engagesthe sensor subassembly.
 33. The apparatus of claim 32, wherein theinsertion mechanism is further configured to be removed from thetransmitter mount after the second portion of the glucose sensor isinserted through the skin surface and in fluid contact with the bodilyfluid of the user.
 34. The apparatus of claim 32, wherein the insertionmechanism is configured to position the sensor subassembly in thetransmitter mount while the transmitter mount is secured to the skinsurface of the user by an adhesive layer.
 35. The apparatus of claim 32,wherein the insertion mechanism is further configured to position thesensor subassembly in the transmitter mount from a first position to asecond position, wherein in the second position, the first portion ofthe analyte sensor and the sensor seal are secured against the base ofthe transmitter mount by the locking mechanism before the transmitter isreceived in the transmitter mount.